EYEMATE-SC Trial: Twelve-Month Safety, Performance, and Accuracy of a Suprachoroidal Sensor for Telemetric Measurement of Intraocular Pressure.

Abstract

PURPOSE:

Measuring and controlling intraocular pressure (IOP) provide the foundation for glaucoma treatment. Self-tonometry has been proposed as an alternative to measure IOP throughout the entire day better. The novel EYEMATE-SC sensor (Implandata) is implanted in the suprachoroidal space to enable contactless continual IOP monitoring. The aim of the present study was to investigate the 1-year safety, performance, and accuracy of the EYEMATE-SC in patients with primary open-angle glaucoma undergoing simultaneous nonpenetrating glaucoma surgery (NPGS).

DESIGN:

Prospective, multicenter, open-label, single-arm, interventional clinical trial.

PARTICIPANTS:

Twenty-four eyes of 24 patients with primary open-angle glaucoma who were due to undergo NPGS (canaloplasty or deep sclerectomy).

METHODS:

An EYEMATE-SC sensor was implanted during NPGS. Goldmann applanation tonometry (GAT) measurements were compared with the sensors' IOP measurements at all postoperative visits through 12 months.

MAIN OUTCOME MEASURES:

Device position and adverse events.

RESULTS:

Fifteen eyes underwent canaloplasty, and 9 underwent deep sclerectomy. Successful implantation of the sensor was achieved in all eyes with no reported intraoperative difficulties. Through the 12-month follow-up, no device migration, dislocation, or serious device-related complications were recorded. A total of 536 EYEMATE-SC measurements were pairwise included in the IOP agreement analysis. The overall mean difference between GAT and EYEMATE-SC measurements was 0.8 mmHg (95% confidence interval [CI] of the limits of agreement [LoA], -5.1 to 6.7 mmHg). The agreement gradually improved, and from 3 months after surgery until the end of the follow-up, the mean difference was -0.2 mmHg (95% CI of LoA, -4.6 to 4.2 mmHg) over a total of 264 EYEMATE-SC measurements, and 100% of measurements were within ±5 mmHg of GAT.

CONCLUSIONS:

The EYEMATE-SC sensor was safe and well tolerated through 12 months. Moreover, it allowed accurate, continuous IOP monitoring.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found after the references.

• Authors: Peter Szurman, Kevin Gillmann, Anna-Maria Seuthe, H Burkhard Dick, Esther M Hoffmann, Andre Mermoud, Marc J Mackert, Robert N Weinreb, Harsha L Rao, Kaweh Mansouri, EYEMATE-SC Study Group
• Journal: Ophthalmology (Ophthalmology) Vol. 130 Issue 3 Pg. 304-312 (03 2023) ISSN: 1549-4713 [Electronic] United States
• PMID: 36202141 (Publication Type: Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2022. Published by Elsevier Inc.

Chemical References

• N-palmitoylgalactosylsphingosine

Topics

• Humans
• Intraocular Pressure
• Glaucoma, Open-Angle
• Prospective Studies
• Reproducibility of Results
• Tonometry, Ocular